Abstract:
The purpose of validation is to provide documented proof that a process has been developed
according to the rules and that it is under control. The objective of our work is to analyze
data from the initial validation and continuous verification of an industrial process for
manufacturing film-coated tablets. For this, we used several tools such as risk analysis via
the FMECA method and the Ishikawa or 5M diagram, the development of control charts and
the process capability study. We applied these analysis techniques on data from 3 consecutive
validation batches, as stipulated by GMP. For the analysis of the risks relating to the process,
we took into account the steps of wet granulation, compression and film coating. The analysis
of the risks relating to the product was limited to the compression and film-coating stages.
The control cards concerned the following quality attributes: average mass, hardness,
thickness.
